Electrosurgical Pads - GBS-Db 1031bc

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K233615

Identifiers

510(k) Number: K233615 FDA 510(k)
FDA Product Code: GEI FDA 510(k)
Models / Variants: GBS-Dm 1030ac FDA 510(k)EUDAMED
GBS-Db 1031ac FDA 510(k)EUDAMED
GBS-Dm 1030a FDA 510(k)EUDAMED
GBS-Db 1031a FDA 510(k)EUDAMED
GBS-Dm 1130ac FDA 510(k)EUDAMED
GBS-Db 1131ac FDA 510(k)EUDAMED
GBS-Dm 1130a FDA 510(k)EUDAMED
GBS-Db 1131a FDA 510(k)EUDAMED
GBS-Dm 1040ac FDA 510(k)EUDAMED
GBS-Db 1041ac FDA 510(k)EUDAMED
GBS-Dm 1040a FDA 510(k)EUDAMED
GBS-Db 1041a FDA 510(k)EUDAMED
GBS-Dm 1140ac FDA 510(k)EUDAMED
GBS-Db 1141ac FDA 510(k)EUDAMED
GBS-Dm 1140a FDA 510(k)EUDAMED
GBS-Db 1141a FDA 510(k)EUDAMED
GBS-Db 4030c FDA 510(k)EUDAMED
GBS-Db 4030 FDA 510(k)EUDAMED
GBS-Db 4040c FDA 510(k)EUDAMED
GBS-Db 4040 FDA 510(k)EUDAMED
GBS-Dm 1030bc FDA 510(k)EUDAMED
GBS-Db 1031bc FDA 510(k)EUDAMED
GBS-Dm 1030b FDA 510(k)EUDAMED
GBS-Db 1031b FDA 510(k)EUDAMED
GBS-Dm 1130bc FDA 510(k)EUDAMED
GBS-Db 1131bc FDA 510(k)EUDAMED
GBS-Dm 1130b FDA 510(k)EUDAMED
GBS-Db 1131b FDA 510(k)EUDAMED
GBS-Dm 1030nc FDA 510(k)EUDAMED
GBS-Db 1031nc FDA 510(k)EUDAMED
GBS-Dm 1030n FDA 510(k)EUDAMED
GBS-Db 1031n FDA 510(k)EUDAMED
GBS-Dm 1 FDA 510(k)EUDAMED

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 878.4400 FDA 510(k)
Regulation Number: 878.4400 FDA 510(k)
Advisory Committee: General, Plastic Surgery FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Electrosurgical Pads are disposable, insulated grounding pads designed for use with electrosurgical units. They provide a conductive pathway for electrical current during surgical procedures, ensuring safe and effective tissue coagulation, cutting, or desiccation by dispersing the current away from the patient’s body.

These pads are intended for single-use and must be inspected for damage before use. Supplied sterile in sealed packaging, they are classified under product code GEI and have received FDA 510K clearance as substantially equivalent. The models vary in size and configuration, including variants such as GBS-Dm and GBS-Db, and are regulated under the Medical Device Directive (MDD).

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K233615	Class II	Active

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Manufacturer

Manufacturer: Baisheng Medical Co., Ltd.

Sources (2)

FDA 510(k) K233615 24 fields · synced Oct 6, 2026
EUDAMED 1 fields · synced May 18, 2026